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Last Updated: January 20, 2025

Investigational Drug Information for N,N-Dimethyltryptamine


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What is the development status for investigational drug N,N-Dimethyltryptamine?

N,N-Dimethyltryptamine is an investigational drug.

There have been 31 clinical trials for N,N-Dimethyltryptamine. The most recent clinical trial was a Phase 2 trial, which was initiated on November 1st 2021.

The most common disease conditions in clinical trials are Depression, Depressive Disorder, and Depressive Disorder, Major. The leading clinical trial sponsors are Johns Hopkins University, University Hospital, Basel, Switzerland, and Universidade Federal do Rio Grande do Norte.

Recent Clinical Trials for N,N-Dimethyltryptamine
TitleSponsorPhase
Acute Analgesic Effects of DMT on Experimentally Induced Pain in Healthy ParticipantsUniversity Hospital, Basel, SwitzerlandPhase 1
Safety, Tolerability and Antidepressant Effects of DMT in Patients With DepressionUniversidade Federal do Rio Grande do NortePhase 2
Safety and Tolerability of DMT in Healthy AdultsUniversidade Federal do Rio Grande do NortePhase 1

See all N,N-Dimethyltryptamine clinical trials

Clinical Trial Summary for N,N-Dimethyltryptamine

Top disease conditions for N,N-Dimethyltryptamine
trials012345678910111213DepressionDepressive DisorderDepressive Disorder, MajorDisease[disabled in preview]
Top clinical trial sponsors for N,N-Dimethyltryptamine
trials01234567891011Johns Hopkins UniversityUniversity Hospital, Basel, SwitzerlandUniversidade Federal do Rio Grande do Norte[disabled in preview]

See all N,N-Dimethyltryptamine clinical trials

N,N-Dimethyltryptamine (DMT): Development Updates and Market Projections

Introduction to DMT

N,N-Dimethyltryptamine (DMT) is a powerful psychedelic compound that has been gaining significant attention in recent years for its potential therapeutic applications. Here, we will delve into the current development updates and market projections for DMT as a drug candidate.

Current Development Updates

Phase 1 Clinical Trials

Several companies are actively involved in the clinical development of DMT. For instance, Cybin Inc. has initiated first-in-human dosing of CYB004, a deuterated DMT molecule, in a three-part Phase 1 clinical trial. This trial aims to evaluate the safety, pharmacokinetics, and pharmacodynamics of escalating doses of CYB004 in healthy volunteers. The study is being conducted at the Centre for Human Drug Research in the Netherlands and is notable for being one of the largest Phase 1 DMT clinical trials to date[1].

Another significant development comes from Algernon Pharmaceuticals, which has completed its Phase 1 clinical study of an intravenous (IV) formulation of DMT (AP-188). The study confirmed the safety and tolerability of the highest dose tested, paving the way for Phase 2 studies focused on the treatment of stroke and traumatic brain injury (TBI)[4].

Phase 2 Clinical Trials

Small Pharma Inc. has also made substantial progress with its DMT candidate, SPL026. The company has initiated a Phase IIa clinical trial to explore the effectiveness of DMT-assisted therapy in combination with psychotherapy for the treatment of Major Depressive Disorder (MDD). This trial marks the world’s first regulated clinical trial for DMT-assisted therapy targeting MDD[3].

Algernon Pharmaceuticals is set to accelerate into Phase 2 studies, investigating DMT for the treatment of stroke and TBI. The success of their Phase 1 study has established a safe single-dose regimen, which will be used in the upcoming Phase 2 trials[4].

Therapeutic Potential

Mental Health Treatment

DMT is being explored for its potential in treating mental health disorders, particularly Major Depressive Disorder (MDD). The combination of DMT with psychotherapy is showing promise in clinical trials, offering a new therapeutic approach for a condition that affects millions of people worldwide[3].

Stroke and Traumatic Brain Injury

Algernon Pharmaceuticals is pioneering the use of DMT for the treatment of stroke and TBI. The company believes that DMT could offer a novel therapeutic option for these conditions, which are currently underserved by existing treatments[4][5].

Market Projections

Global Psychedelic Drug Market

The global psychedelic drug market is expected to grow significantly over the next decade. By 2034, the market is projected to reach $1.18 billion, growing at a Compound Annual Growth Rate (CAGR) of 7% from 2024 to 2034. DMT is anticipated to play a substantial role in this growth, with demand increasing at a CAGR of 7.7% during the same period[2].

Regional Market Focus

The United States is a key market for psychedelic drugs, including DMT. The U.S. market is expected to grow from $64.1 million in 2024 to $131.5 million by 2034, driven by FDA approvals and the increasing recognition of psychedelic compounds for mental health treatment[2].

Key Companies Involved

Several companies are at the forefront of DMT research and development:

  • Cybin Inc.: Focused on the development of CYB004, a deuterated DMT molecule.
  • Small Pharma Inc.: Conducting Phase IIa clinical trials for DMT-assisted therapy for MDD.
  • Algernon Pharmaceuticals: Investigating DMT for the treatment of stroke and TBI.

These companies, along with others like Revive Therapeutics and Mind Medicine, are driving innovation and advancement in the field of psychedelic-assisted therapies[2].

Safety and Pharmacokinetics

The safety and pharmacokinetics of DMT are critical aspects of its development. Studies have shown that DMT can be safely administered in controlled clinical settings. For example, Algernon Pharmaceuticals’ Phase 1 study confirmed the safety of a single sub-psychedelic dose of DMT, which is a crucial step towards further clinical development[4].

Cybin Inc.’s CYB004 is designed to overcome existing limitations of DMT, such as its short duration of action, and is protected by a composition of matter patent through 2041. This deuterated version of DMT aims to provide a more stable and longer-lasting therapeutic effect[1].

Future Outlook

As clinical trials progress and more data becomes available, the therapeutic potential of DMT is likely to become more defined. Here are some key points to consider:

  • Regulatory Approvals: FDA approvals and other regulatory clearances will be pivotal in the commercialization of DMT-based therapies.
  • Market Expansion: The growing recognition of psychedelic drugs for mental health and other conditions will drive market expansion.
  • Therapeutic Applications: DMT’s potential in treating a range of conditions, from MDD to stroke and TBI, makes it a versatile candidate with significant therapeutic potential.
"DMT-assisted therapy has the potential to offer a new therapeutic treatment for MDD, a disorder that devastates the lives of millions of people every year." - Dr. Carol Routledge, Chief Medical and Scientific Officer of Small Pharma[3].

Key Takeaways

  • Clinical Trials: Multiple Phase 1 and Phase 2 clinical trials are underway to evaluate the safety and efficacy of DMT for various conditions.
  • Therapeutic Potential: DMT shows promise in treating mental health disorders, stroke, and TBI.
  • Market Growth: The global psychedelic drug market, including DMT, is projected to grow significantly over the next decade.
  • Key Companies: Companies like Cybin Inc., Small Pharma Inc., and Algernon Pharmaceuticals are leading the development of DMT-based therapies.

FAQs

What is DMT and how does it work?

DMT is a powerful psychedelic compound that acts by activating the 5-HT receptors in the brain. It is being explored for its therapeutic potential in treating various conditions, including mental health disorders and neurological injuries.

What are the current clinical trials for DMT?

Several companies are conducting clinical trials for DMT, including Cybin Inc.'s Phase 1 trial for CYB004, Small Pharma Inc.'s Phase IIa trial for SPL026, and Algernon Pharmaceuticals' Phase 1 and upcoming Phase 2 trials for AP-188.

What are the potential therapeutic applications of DMT?

DMT is being investigated for its potential in treating Major Depressive Disorder (MDD), stroke, and traumatic brain injury (TBI), among other conditions.

How is the market for DMT projected to grow?

The global psychedelic drug market, which includes DMT, is expected to grow at a CAGR of 7% from 2024 to 2034, reaching $1.18 billion by 2034.

Which companies are leading the development of DMT-based therapies?

Key companies involved in DMT research and development include Cybin Inc., Small Pharma Inc., and Algernon Pharmaceuticals.

What are the safety concerns associated with DMT?

Clinical trials have shown that DMT can be safely administered in controlled settings. However, its use must be carefully monitored due to its potent psychedelic effects.

Sources

  1. Cybin Inc. - "Cybin Initiates First-in-Human Dosing of CYB004 in Phase 1 Clinical Trial" - Biospace.
  2. Fact.MR - "Psychedelic Drug Market size, share & Growth Analysis 2034".
  3. Small Pharma Inc. - "First Patient Dosed in Phase IIa DMT-Assisted Therapy Clinical Trial" - Psychedelic Alpha.
  4. Algernon Pharmaceuticals - "DMT study to progress investigations into TBI and stroke" - Psychedelic Health.
  5. Algernon Pharmaceuticals - "Algernon Pharmaceuticals Launches Stroke Treatment Clinical Research Program with Psychedelic Drug DMT" - Biospace.

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